Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH MEDICAL USA, INC. ADD VBR SMALL; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ULRICH MEDICAL USA, INC. ADD VBR SMALL; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Back to Search Results
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348)
Event Date 01/22/2016
Event Type  Injury  
Event Description
Literature reports following c6 anterior cervical corpectomy and fusion involving an expandable lordotic cage add plus vbr [k09841].Patient suffered device-related cervicobrachialgia requiring revision surgery.Imaging studies reveal the device center expandable strut broke, causing injury and need for revision.Device indication and labeling cleared only for non-cervical uses.Yet device construct and design rationale configured to conform for cervical use which is not within the scope of the 510k intended use and indication [trieb, klemens, and stephan koch."failure of an expandable cage plate cervical vertebral body replacement: case report of a device related complication." joint disease and related surgery 28.3 (2017): 214-218].Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ADD VBR SMALL
Type of Device
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Manufacturer (Section D)
ULRICH MEDICAL USA, INC.
MDR Report Key8654407
MDR Text Key146677620
Report NumberMW5086978
Device Sequence Number1
Product Code MQP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 05/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/29/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age49 YR
Patient Weight59
-
-